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Panel: The Role of User Centered Design in Next-Gen Medical Product Development

Tor Alden  (Principal, HS Design, Inc.)

John Anastasiadis  (Director, Human Factors+Design, Smith+Nephew)

Aleksandar Vacic  (Chief Operating Office and Co-founder, Selux Diagnostics, Inc.)

MaryBeth Privitera, PhD  (Principal, HFE/Research, HS- Design, Inc.)

Location: Biomed Room 2

Date: Wednesday, September 16

Time: 9:30 am - 10:15 am

Track: Track B: Next-Generation Design Trends & Innovation Strategies

Vault Recording: TBD

Uncovering user needs for 1st generation medical products is now an important aspect for the FDA. There is an increased demand for access to hospitals, labs, caregivers and patients for new devices ranging from combination products to medical devices. Products are crossing boundaries from pharmaceutical and biologic delivery systems forcing a need for increased collaboration in the design of complex systems in the medical and life science device development. This panel will focus on research methodologies and case studies to challenge existing processes when trying to uncover the user needs of new first-of-kind and high technology, complex medical systems. Additionally, the collaboration needed with systems engineering to concurrently develop and test user and product requirements prior to translating the user needs and technical requirements to design, marketing, and engineering organizations will be discussed.

Topics include:

  • Challenges and opportunities for collecting user input
  • Understanding how to best document and present user needs to FDA
  • Capturing and translating user needs early for product pivots